Catheter-based tissue remodeling devices and methods

ABSTRACT

Methods and systems for closing an opening or defect in tissue, closing a lumen or tubular structure, cinching or remodeling a cavity or repairing a valve preferably utilizing a purse string or elastic device. The preferred devices and methods are directed toward catheter-based percutaneous, transvascular techniques used to facilitate placement of the devices within lumens, such as blood vessels, or on or within the heart to perform structural defect repair, such as valvular or ventricular remodeling. In some methods, the catheter is positioned within the right ventricle, wherein the myocardial wall or left ventricle may be accessed through the septal wall to position a device configured to permit reshaping of the ventricle. The device may include a line or a plurality of anchors interconnected by a line. In one arrangement, the line is a coiled member.

RELATED APPLICATIONS

This application is related to, and claims priority from, U.S.Provisional Patent Application No. 60/702,823, filed Jul. 27, 2005, andU.S. Provisional Patent Application No. 60/673,838, filed Apr. 22, 2005,the entireties of which are hereby incorporated by reference herein andmade a part of the present disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to systems and methods for remodeling softtissue of a patient. More specifically, the present invention relates todrawing tissue portions toward one another to, for example, reduce orclose body cavities or lumens, such as heart chambers, heart valves andother generally hollow anatomical structures.

2. Description of the Related Art

Several surgical techniques have been developed to close defects intissue, reduce or close tubular structures, remodel cavities and repairbodily valves. However, the existing techniques require surgery or, evenif n-on-invasive, suffer from significant drawbacks. For example,existing techniques may be generally difficult to perform, leave largeresidual foreign materials in the body, or not very effective inachieving the desired results.

For example, with respect to vascular or heart tissue remodeling,minimally invasive methods are fairly complex and often leave devices,such as stents, umbrellas, disks, plugs or rods, within a blood pathwayof the body, which could promote thrombus formation. With respect tomitral or aortic regurgitation, minimally invasive methods typicallyinsert a rod or similar apparatus within the coronary sinus. However,such a method could lead to erosion of the coronary sinus or otherproblems to the patient. Alternative devices and methods that attach thevalve leaflets together to reduce regurgitation could lead to tears inthe leaflets, which could require further surgery.

To properly and consistently repair the mitral valve, the followingvariables are relevant: the annular diameter, the leaflet length, thechordal length and the attachment point of the chords. Fortunately, theleaflet length is relatively constant. The annulus diameter can be fixedby the annuloplasty ring. The chords can be replaced bypolytetrofluorethylene suture to fix their length. The missing variableis the attachment of the chords to the left ventricle. To date, thisremains a troublesome variable to the valve repair.

Ischemic mitral regurgitation occurs when there is ventriculardysfunction which causes the posterolateral attachments of the mitralvalve to be drawn away from the annulus in systole. This pulls the twoleaflet edges apart at their point of coaptation and produces anasymmetrical regurgitate jet or, in other words, blood flow in the wrongdirection through the valve. In an ideal situation, the leaflets, thechords and the attachment points are all anatomically normal. Sometimesthere is a relative discrepancy between the distances the anteriorleaflet is drawn inward relative to the posterior leaflet so they arenot just separated from edge-to-edge but also there is a step deformityof the junction point. The patient may also have some underlying milddegree of degenerative deformity which may initially cause a mild, butwell-tolerated degree of mitral regurgitation. However, theregurgitation often becomes severe after left ventricular ischemiaoccurs.

Some repair techniques apply tight annuloplasty rings which serve tobuckle the leaflets and draw them together to, for example, correctischemic disease. This often leaves a degree of mitral regurgitation andmitral stenosis results. However, long term results seem to degenerateafter a couple of years due to the continuing of the dilation in theventricle it self, which changes the attachment point position in regardof the annulus and by pulling on the chords, the leaflet edges will nolonger coapt, thereby producing regurgitation. Accordingly, a needexists for improved minimally invasive tissue remodeling devices andmethods in general, and particularly for the purpose of adjusting thelocation of the attachment of the chords to the left ventricle relativeto the valve annulus.

SUMMARY OF THE INVENTION

Preferred systems and methods of the present invention permit remodelingof soft tissue structures using minimally invasive techniques, whichpreferably are catheter based. In many arrangements, the systems andmethods leave little or no foreign objects within fluid pathways of thebody. In certain preferred embodiments, a purse string device is placedwithin a body cavity or tubular structure to reduce or completely closethe cavity or structure. The preferred systems and methods are wellsuited for use in structural defect repair, including treatment of heartvalve insufficiency, heart ventricle remodeling, and closure of avessel. In some arrangements, the purse string device may be a sutureand, in other arrangements, the purse string device may be a coiledmember.

A preferred method includes positioning a distal end of a catheterproximate a body structure and securing a plurality of anchors to tissueof the body structure comprising advancing a piercing member into a wallof the body structure by passing the member through an inner surface ofthe wall of the body structure. Tissue anchors are deployed from thepiercing member such that at least a portion of the anchor contacts theouter surface of the wall of the body structure. A force is applied to apurse string to draw at least some of the anchors towards each other.

A preferred method includes providing a catheter comprising a pluralityof tissue anchors and positioning a distal end of the catheter proximatea body structure. The plurality of tissue anchors are substantiallysimultaneously secured at respective spaced locations within the bodystructure. The securing comprises advancing a distal-most end of thecatheter into contact with tissue at the spaced locations.

A preferred method includes providing a catheter comprising a guidecatheter and a plurality of delivery catheters having a curved pre-shapeand carrying respective tissue anchors. The delivery catheters aredisposed within the guide catheter. A distal end of the catheter ispositioned proximate a body structure. The plurality of tissue anchorsare secured at respective spaced locations within the body structure byadvancing the plurality of delivery catheters through the guide cathetersuch that distal end portions of the delivery catheters protrude from adistal end of the guide catheter. The securing comprises positioning theanchors at respective distal ends of the delivery catheters and allowingthe distal portions of the delivery catheters to move towards the curvedpre-shape as the distal portions of the delivery catheters are advanced.

A preferred method of closing a fallopian tube includes positioning adistal end of a catheter at a location within the fallopian tube. Thecatheter is used to secure respective tissue anchors at at least threespaced locations in a wall of the tube. At least some of the tissueanchors are relatively moved by applying a force to a purse string suchthat the locations are drawn towards each other.

A preferred method of closing a fallopian tube includes positioning adistal end of a catheter at a location within the fallopian tube. Thecatheter is used to secure respective tissue anchors at at least threespaced locations in a wall of the tube. A line is serially threadedthrough the tissue anchors. Respective portions of the line are drawnthrough at least some of the tissue anchors such that the locations aredrawn towards each other.

A preferred method of repairing a heart valve includes introducing adistal end of a catheter through vasculature to a location proximate aheart valve. The catheter is used to secure respective tissue anchors atat least three spaced locations adjacent the valve. At least some of thetissue anchors are relatively moved by applying a force to a pursestring such that the valve leaflets are repositioned to improve valvefunction.

A preferred method of repairing a heart valve includes introducing adistal end of a catheter through vasculature to a location proximate aheart valve. The catheter is used to secure respective tissue anchors atat least three spaced locations adjacent the valve. A line is seriallythreaded through the tissue anchors. Respective portions of the line aredrawn through at least some of the tissue anchors such that the valveleaflets are repositioned to improve valve function.

A preferred method of reshaping a heart ventricle includes introducing adistal end of a catheter into the ventricle through vasculature. Thecatheter is used to secure respective tissue anchors at at least threespaced locations in a wall of the ventricle. At least some of the tissueanchors are relatively moved by applying a force to a purse string suchthat the ventricle is reshaped.

A preferred method of reshaping a heart ventricle includes introducing adistal end of a catheter into the ventricle through vasculature. Thecatheter is used to secure respective tissue anchors at at least threespaced locations in a wall of the ventricle. A line is serially threadedthrough the tissue anchors. Respective portions of the line are drawnthrough at least some of the tissue anchors such that the ventricle isreshaped.

A preferred apparatus includes a catheter comprising a purse stringinterconnected with a plurality of tissue anchors configured to besecured to one of heart tissue, blood vessel tissue, or fallopian tubetissue, such that, in use, force on the purse string moves at least someof the secured tissue anchors to reshape the heart, improve heart valvefunction, or close a fallopian tube, respectively.

A preferred method of repositioning leaflets of a mitral valve of aheart to improve valve function includes advancing a distal end of acatheter through an opening in the septal wall of the heart and into theleft ventricle of the heart. A purse string is provided. The catheter isused to secure the purse string at a plurality of locations adjacent aninner surface of the wall of the ventricle. A force is applied to thepurse string to alter the shape of the left ventricle such that theleaflets are repositioned to improve the function of the valve.

A preferred method of repositioning leaflets of a mitral valve of aheart to improve valve function includes providing a plurality ofanchors in tissue of a wall of a ventricle such that at least some ofthe anchors are interconnected by an elastic member. The anchors arepositioned such that the elastic member is in tension so as toelastically draw at least some of the anchors toward one another toalter the shape of the left ventricle such that the leaflets arerepositioned to improve the function of the valve.

A preferred method of repositioning leaflets of a mitral valve of aheart to improve valve function include advancing a distal end of acatheter into a right chamber of the heart. The catheter is used toadvance a line through the wall of the left ventricle in a directionparallel to inner and outer surfaces of the wall such that the lineextends along the wall generally parallel to the surfaces substantiallyfrom a location on one side of the heart to a location on an oppositeside of the heart. A force is applied to the line to alter the shape ofthe left ventricle such that the leaflets are repositioned to improvethe function of the valve.

A preferred method of repositioning leaflets of a mitral valve of aheart to improve valve function includes advancing respective distalends of first and second guide catheters into a right chamber of theheart and through respective spaced locations in the septal wall to theleft ventricle. The guide catheters are used to facilitate positioningof an anchor positioning member in the left ventricle. The anchorpositioning member is oriented so as to extend from one side of theventricle to another. The anchor positioning member is used to secure aplurality of anchors to the wall of the ventricle by pressing theanchors against tissue. At least some of the anchors are drawn towardone another to alter the shape of the left ventricle such that theleaflets are repositioned to improve the function of the valve.

A preferred method of repositioning leaflets of a mitral valve of aheart to improve mitral valve function includes providing an elongateanchor positioning member and a series of anchor stowage membersdisposed serially in spaced relationship along the anchor positioningmember. The elongate anchor positioning member is pressed against a wallof the ventricle such that the positioning member supports the stowagemembers adjacent the wall. Respective anchors are driven out of thestowage members and into ventricular tissue while the anchor positioningmember supports the stowage members. The anchor positioning member isremoved from the ventricle. A line interconnecting the anchors is usedto apply force to the anchors and thereby alter the shape of theventricle such that the leaflets are repositioned to improve valvefunction.

A preferred apparatus for altering the shape of a ventricle of a heartincludes a catheter configured to be introduced into a heart chamberthrough vasculature. The catheter has a sharp distal end which boresthrough tissue so as to form a passage therethrough. The catheter alsohas a steering member which steers the sharp distal end throughventricular tissue generally parallel to inner and outer wall of theventricle. The steering member is configured to follow the sharp distalend through the passage. The sharp distal end is connected to a linedetachable from the distal end. The line is sized to extend through thepassage such that tension on the line alters the shape of the ventricle.

A preferred apparatus for altering the shape of a ventricle of a heartincludes an elongate anchor positioning member. A plurality of anchorstowage members are disposed serially in spaced relationship along theanchor positioning member. A plurality of anchors stowed withinrespective anchor stowage members. The anchors are interconnected by aline. The anchor positioning member is configured to support the anchorstowage members adjacent to a ventricular wall. An actuator drives theanchors from the anchor stowage members into ventricular tissue whilethe anchor positioning member supports the anchor stowage members.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the present tissueremodeling devices and methods are described in greater detail belowwith reference to drawings of several preferred embodiments, which areintended to illustrate, but not to limit, the present invention. Thedrawings contain 48 figures.

FIG. 1 is a perspective view of a tissue remodeling system havingcertain features, aspects and advantages of the present invention. Thetissue remodeling system of FIG. 1 includes a catheter assemblyincluding several coaxial catheter bodies.

FIG. 2 is a longitudinal cross-sectional view of a distal end of thecatheter of FIG. 1.

FIGS. 3 a and 3 b are radial cross-section views of the catheter of FIG.1 illustrating two alternative cross-sectional shapes of a deliverycatheter of the catheter assembly.

FIG. 4 is a side view of the catheter of FIG. 1 contacting soft tissueof a patient. The catheter of FIG. 1 includes an inflatable balloonconfigured to provide an atraumatic tissue contact surface.

FIGS. 5 a through 5 f illustrate the catheter of FIG. 1 at variouspositions while being utilized to place tissue anchors at desiredpositions in the soft tissue of a patient.

FIGS. 6 a and 6 b illustrate the tissue anchors and a purse string beingutilized to reduce the cross-sectional dimension of a body lumen, suchas a blood vessel, for example. FIG. 6 a illustrates the purse stringdevice prior to the reduction of the cross-sectional dimension of thelumen and FIG. 6 b illustrates the purse string device having beenutilized to draw at least a portion of the tissue anchors towards oneanother to reduce the cross-sectional dimension of the lumen.

FIGS. 7 a and 7 b illustrate the tissue anchors and purse string beingutilized to close the body lumen, such as a fallopian tube, for example.FIG. 7 a illustrates the tissue anchors and purse string in place withinthe lumen prior to reduction of the cross-sectional dimension and FIG. 7b illustrates the tissue anchors and purse string after the purse stringhas been utilized to draw at least a portion of the tissue anchorstowards one another to close the body lumen.

FIGS. 8 a through 8 c illustrate the catheter of FIG. 1 being utilizedto deliver multiple purse string devices within the left ventricle of apatient's heart. The multiple purse string devices may be used toremodel, or reduce the volume, of the left ventricle to treat, forexample, congestive heart failure. The devices may be used to remodelother heart chambers and other bodily cavities, as well.

FIG. 9 is a perspective view of one preferred tissue anchor.

FIG. 10 is a side view of the tissue anchor of FIG. 9.

FIG. 11 is a perspective view of a modification of the tissue anchor ofFIGS. 9 and 10. FIG. 11 shows the front, top and a first side of thetissue anchor in a relaxed or unconstrained position.

FIG. 12 is a perspective view of the tissue anchor of FIG. 11illustrating the front, top and a second side of the tissue anchor,opposite the side from FIG. 1.

FIG. 13 illustrates the tissue anchor of FIGS. 11 and 12 in a collapsedor constrained position.

FIG. 14 is another view of the tissue anchor of FIGS. 11 and 12 in thecollapsed position and rotated about its longitudinal axis byapproximately ninety degrees from the view of FIG. 13.

FIG. 15 illustrates a pair of the tissue anchors of FIGS. 11 through 14implanted within soft tissue of a patient and interconnected by a line,such as a suture, for example.

FIG. 16 a and 16 b illustrate the catheter of FIG. 1 being utilized toremodel an aortic valve of a patient's heart.

FIGS. 17 a and 17 b illustrate the catheter of FIG. 1 being utilized toremodel the mitral valve of a patient's heart. Specifically, in FIGS. 17a and 17 b, the catheter is utilized to place a plurality of tissueanchors interconnected by a purse string device within a wall of theleft ventricle to reposition the papillary muscles and, thus, the mitralvalve leaflets.

FIG. 18 is a cross-sectional view of a heart including an opening in aninternal wall of the heart between the right atrium and left atrium,which is often referred to as a PFO (patent foramen ovale).

FIG. 19 illustrates the catheter of FIG. 1 being utilized to close thePFO of a patient's heart.

FIGS. 20 a and 20 b illustrate the catheter of FIG. 1 being utilized torepair the PFO. FIGS. 20 a and 20 b are views of the heart taken alongthe line 20-20 of FIG. 19.

FIG. 21 is a side view of another tissue remodeling system havingcertain features, aspects and advantages of the present invention. Adistal end of the catheter assembly of FIG. 21 is illustrated incross-section to reveal multiple delivery tubes within the guidecatheter of FIG. 21.

FIG. 22 illustrates the distal end of the catheter assembly of FIG. 21with the pre-curved delivery catheters deployed from the guide catheter.

FIG. 23 illustrates the distal end of the catheter of FIG. 21 with thedelivery catheters deployed from the guide catheter and tissue anchorsdeployed from each of the delivery catheters. A line, such as a suture,interconnects each of the tissue anchors.

FIG. 24 is an enlarged view of a preferred embodiment of a tissue anchorwithin a delivery catheter of the catheter assembly of FIG. 21.

FIG. 25 illustrates the tissue anchor of FIG. 24 deployed from thedelivery catheter.

FIGS. 26 a through 26 e illustrate the catheter of FIG. 21 beingutilized to remodel an aortic valve of a patient's heart.

FIG. 27 is a perspective view of another preferred tissue remodelingsystem including a catheter assembly having certain features, aspectsand advantages of the present invention.

FIG. 28 is a longitudinal cross-sectional view of a distal end of thecatheter of FIG. 27 illustrating a tissue anchor delivery catheterwithin a guide catheter.

FIG. 29 is an end view of a distal end of the guide catheter of FIG. 28.

FIG. 30 illustrates the catheter of FIG. 27 being utilized to delivertissue anchors into soft tissue of a patient.

FIG. 31 is a perspective view of a preferred system for remodeling softtissue of a patient including a catheter assembly. The catheter assemblyincludes a linear coil purse string device.

FIG. 32 is an enlarged view of the linear coil purse string device.

FIG. 33 illustrates the linear coil purse string device with multipletissue anchors deployed therefrom.

FIG. 34 is an enlarged view of a tissue anchor stowage device carried bythe linear coil purse string device.

FIG. 35 illustrates a deployment mechanism configured to deploy thetissue anchors from the tissue anchors stowage devices.

FIG. 36 illustrates a tissue anchor being deployed from the tissueanchor stowage device. In addition, FIG. 36 illustrates a support rodwhich is configured to hold the tissue anchor stowage devices at adesired position relative to one another prior to deployment of thetissue anchors. The support rod preferably is removed once the anchorsare deployed to permit the linear coil purse string device to contractand thereby remodel soft tissue.

FIG. 37 is a vertical cross-sectional view of a patient's heartillustrating a preferred path of access to the left ventricle from theright ventricle and through the septal wall.

FIG. 38 is a horizontal cross-sectional view of the heart illustratingthe preferred access path of FIG. 37.

FIGS. 39 a through 39 h illustrate the catheter of FIG. 1 being used todeliver a purse string device, which includes a plurality of tissueanchors, to remodel the left ventricle of a patient's heart.

FIGS. 40 a through 40 h illustrate a preferred method of deployment ofmultiple tissue anchors interconnected by a line, such as a suture,within the left ventricle of a patient. Preferably, the tissue anchorsand suture are deployed with the system of FIGS. 27-29.

FIGS. 41 a and 41 b illustrate a preferred method of utilizing a linearcoil purse string device to remodel the left ventricle of a heart.

FIG. 42 a illustrates another preferred arrangement of multiple pursestrings within the left ventricle, wherein the purse string rowsoriginate from a common point and are inclined relative to one another.FIG. 42 b illustrates a first arrangement of multiple purse stringswithin the left ventricle wherein the purse string rows are orientedgenerally parallel to one another.

FIG. 43 is a perspective view of another tissue remodeling systemincluding a catheter assembly having certain features, aspects andadvantages of the present invention. The catheter assembly of FIG. 43includes multiple co-axial components.

FIG. 44 illustrates a tissue tunneling member of the catheter assemblyof FIG. 43.

FIG. 45 illustrates a steering catheter of the catheter assembly of FIG.43.

FIG. 46 illustrates a guide catheter of the catheter assembly of FIG.43.

FIG. 47 illustrates a preferred path of deployment of the system of thecatheter of FIG. 43.

FIGS. 48 a through 48 h illustrate the system of FIG. 43 being utilizedto place a suture within a passage through the myocardial wallsurrounding the left ventricle of a patient's heart.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Preferred embodiments of the present tissue remodeling system facilitateremodeling, tissue joining, or tying of soft tissue preferably in apercutaneous manner utilizing a catheter. In certain preferredarrangements, the system permits a remodeling of the left ventricle of aheart to reduce the volume of the ventricle or reposition papillarymuscles. In addition, the preferred systems may be utilized to remodelvalve structures, such as the aortic or mitral valves of the heart.Certain systems and methods disclosed herein may be well-suited to treatIschemic Mitral Regurgitation (IMR), for example. Further, preferredembodiments may be utilized to reduce the cross-sectional area of bodycavities or lumens, or completely close body cavities or lumens.Preferred methods for remodeling soft tissue are also disclosed.

Preferably, the preferred embodiments permit soft tissue remodelingwhile avoiding the disadvantages of more invasive procedures and thecomplications that may occur as a result of such procedures. Thepreferred embodiments and methods may also permit tissue remodeling inpatients that are otherwise unable to undergo conventional surgicalprocedures. Preferred embodiments of the present system permit theduplication of the results of surgical procedures by percutaneoustransvascular techniques using catheter-based devices. In addition, thepreferred embodiments and methods disclosed herein maybe modified oradopted for use in the remodeling of soft tissue other than the heart orbody lumens. Preferably, the methods described herein are accomplishedwith a suitable imaging technique, or techniques, such astransesophageal echocardiogram (TEE), angiographic fluoroscopy orcineangiographic guidance, for example.

FIGS. 1-3 illustrate a tissue remodeling system having certain features,aspects and advantages of the present invention and is generallyreferred to by the reference numeral 50. The illustrated system 50includes a catheter assembly 52, which preferably includes multiplecatheters, or catheter bodies. For simplicity, both the overall catheterassembly 52 and the individual catheter bodies that make up the catheterassembly 52 may be referred to herein by the term “catheter.”Furthermore, the catheter 52 may include other components as well, suchas tissue anchors, for example. Preferably, the catheter 52 is sized,shaped and otherwise configured to be movable within a patient'svasculature to a desired remodeling site from a desired insertion site.In some arrangements, the insertion site may be the femoral artery, forexample. However, other suitable insertion sites may also be used.

Preferably, the catheter 52 includes multiple components that arecoaxial with one another and are capable of telescopic movement relativeto one another. In the illustrated arrangement, the catheter assembly 52includes a guide catheter 54. A delivery catheter 56 is configured to bereceived within the guide catheter 54 and is movable relative to theguide catheter 54. A tissue piercing or penetrating member, such as aneedle 58, is received within, and is movable relative to, the deliverycatheter 56, as shown in FIG. 2. A pushing mechanism, such as a push rod60, is received within, and movable relative to, the needle 58 and maybe used to deploy tissue anchors 62 (FIG. 2) from the needle 58, as isdescribed in greater below. A line, such as a suture 64, extends throughthe needle 58, interconnects the anchors 62 and extends back through thedelivery catheter 56 such that both ends 64 a and 64 b of the suture 64are external of the proximal end of the catheter assembly 52.

The individual components of the catheter assembly 52 may be constructedfrom any suitable material(s) using any suitable fabrication techniques,such as those commonly known and used in the medical device industry.For example, the guide catheter 54 and delivery catheter 56 maybeconstructed from a suitable polymeric material, such as polyethylene,polyurethane, silicon, or polytetraflouroethylene, for example. Thecatheters 54 and 56 may be constructed by an extrusion process; however,other suitable materials and/or suitable processes may be used. Theneedle 58 and push rod 60 preferably are constructed from a metalmaterial suitable for use in medical applications, such as stainlesssteel or a shape-memory material, for example. However, other suitablematerials and/or suitable fabrication processes may also be used.

As described above, the guide catheter 54 preferably is configured to beintroduced to the patient's vasculature at an introduction site andguided through the vasculature through the desired working site, such asthe heart, for example. Thus, preferably, the guide catheter 54 is of asufficient length such that the distal end of the catheter 54 may reachthe desired work site while the proximal end of the catheter 54 remainsexternal of the patient. The guide catheter 54 may have an outerdiameter of about 26 F (French) and an inner (lumen) diameter of about22 F. However, other dimensions may be employed depending on thespecific use of the catheter 54, as will be appreciated by one of skillin the art.

Preferably, the guide catheter 54 is configured to be steerable topermit the catheter 54 to be guided through vasculature to the desiredwork site or to be steerable once at the work site. For example, adeflection wire (not shown) may be connected to a distal end of theguide catheter 54 and extend within a wall of the catheter 54 to aproximal end of the catheter 54 where it is connected to a control knob66. Thus, the control knob 66 permits the user to selectively push orpull the deflection wire to deflect the distal end of the guide catheter54. Deflection of the distal end of the guide catheter 54 assists a userin routing the catheter 54 through the vasculature of a patient in adesired path or position the distal end of the catheter 54 once at thework site. Such a system is disclosed in greater detail in theapplicant's co-pending U.S. patent application Ser. No. 11/059,866,filed Feb. 17, 2005 and entitled “Catheter Based Tissue RemodelingDevices and Methods,” the entirety of which is incorporated by referenceherein. Alternatively, other suitable steering arrangements orpositioning methods of the guide catheter 54 may be employed. In onearrangement, the guide catheter 54 may be configured to slide over apreviously placed guide wire (not shown) or may be passed through apreviously placed catheter.

Preferably, the distal end of the guide catheter 54 is configured to beatraumatic to the patient and, in particular, to the tissue proximatethe work site. In the illustrated arrangement, the distal tip of theguide catheter 54 carries an inflatable, preferably annular balloon 68.Preferably, the balloon 68 is normally carried by the guide catheter 54in an uninflated condition so as not to interfere with the passage ofthe catheter 54 through a patient's vasculature. Once in place at ornear the work site, the balloon 68 may be inflated such that a distalend of the balloon 68 contacts the patient's soft tissue to helpstabilize the catheter 54 and inhibit the distal tip of the catheter 54from damaging tissue. Preferably, the balloon 68, in an inflatedcondition, extends beyond an end surface of the distal end of thecatheter 54 to create a space 70 between the distal end of the catheter54 and the tissue 72, as illustrated in FIG. 4.

The balloon 68 may be constructed from any suitable material, such assilicon, urethane, Pebax, polyimide and multi-layered polymers, forexample. The balloon 68 may be inflated by a suitable fluid, includingliquid or gas. Preferably, a passage (not shown) extends from a proximalend of the catheter 54 to an internal space of the balloon 68 so that aninflation fluid may be introduced into the balloon 68 from the proximalend of the catheter 54. The passage may be defined within the body ofthe catheter 54 or may be formed by a separate element of the catheterassembly 52.

Desirably, the catheter assembly 52 also includes a system for creatinga vacuum within the space 70 bounded by the balloon 68. The catheterassembly 52 includes a conduit, or tube 74, which is configured to beconnectable to a vacuum pump (not shown). The tube 74 communicates witha passage preferably within the catheter body of the catheter 54 (notshown) which, in turn, communicates with the space 70. Thus, the vacuumpump may be operated to produce a vacuum condition within the space 70to assist in securing the distal end of the catheter 54 at a desiredlocation on the patient's tissue 72. Alternatively, the vacuum passagemay be created by a component of the catheter assembly 52 other than theguide catheter 54.

As described above, the delivery catheter 56 is configured to residewithin the guide catheter 54 and is capable of movement within the guidecatheter 54. The delivery catheter 56 may have an outer diameter ofabout 18 F and an inner (lumen) diameter of about 13 F. However, otherdimensions may be selected to suit a desired application of the catheter56. The delivery catheter 56 may be constructed of any suitable materialor combination of materials, such as polyethylene, polyurethane,silicone or polytetraflouroethylene, for example. Desirably, a proximalend of the catheter 56 includes a handle 76, or hub, which permits auser to grasp and manipulate the catheter 56.

With reference to FIG. 3 a and 3 b, the delivery catheter 56 may take onany suitable cross-sectional shape. As described above, the deliverycatheter 56 is configured to receive the needle 58. In addition,desirably, a length of the suture 64 extends through the deliverycatheter 56 external of the needle 58. To accommodate both the needle 58and the suture 64, preferably the lumen of the catheter 56 defines agenerally circular space 78 to accommodate the needle 58 and anadditional space 80 configured to accommodate the suture 64 adjacent thespace 78. As illustrated in FIG. 3 a, in one arrangement, the space 80may be connected to the space 78 or, as illustrated in FIG. 3 b, thespace 80 may be defined by a separate lumen of the catheter 56.

The needle 58 preferably is configured to stow the tissue anchors 62 anda portion of the suture 64 and facilitate the deployment of the tissueanchors 62 and suture 64. Similar to the delivery catheter 56, theneedle 58 preferably includes a handle, or hub 82, at its proximal endto permit a user to manipulate the needle 58. Furthermore, preferably, adistal tip 84 of the needle 58 is beveled to facilitate tissuepenetration. In one preferred arrangement, the needle 58 is constructedfrom a shape-memory material, such as Nitinol, for example, to provide abeneficial degree of flexibility. However, other suitable materials mayalso be used, such as stainless steel, for example. Further, the needle58 could be of a composite construction to permit the optimization ofcertain characteristics, such as needle penetration and shaftflexibility, for example. The hub 82 may be constructed from a plasticor metal material, for example, through any suitable process, such asmolding or machining.

The suture 64 may also be constructed of any suitable material. Forexample, preferably the material is non-bioabsorbable. However, incertain arrangements, the suture 64 may be constructed from abioabsorbable material, if desired. Further, the material may bemonofilament or multifilament, single strand or braided and a naturalmaterial or a synthetic material. Suitable materials may includePolyglactin (e.g., coated vicryl), Polydioxanone (PDS), Polyamide orNylon (e.g., ETHILON), Polyester (DACRON) or Polypropylene (PROLENE),among others.

FIGS. 5 a-5 f illustrate a preferred method of using the system 50 todeliver tissue anchors that are interconnected by a line, such as thesuture 64, to the soft tissue 72 of a patient. In FIGS. 5 a-5 f, theguide catheter 54 has been omitted for the purpose of clarity. However,preferably the guide catheter 54 is placed against the tissue 72 asdescribed above with reference to FIG. 4.

FIG. 5 a illustrates the needle 58 in suture 64 stowed within thedelivery catheter 56. Accordingly, the needle 58 and suture 64 do notprotrude from a distal end of the delivery catheter 56. FIG. 5 billustrates the delivery catheter spaced a slight distance from the softtissue 72 of the patient. The needle 58 is advanced from the deliverycatheter 56 and carries the suture 64 with it. In FIG. 5 c, the deliverycatheter 56 is advanced until it contacts the tissue 72. In addition,the needle 58 is advanced through the tissue 72, bringing the suture 64along with it. The movement of the delivery catheter 56 into contactwith the tissue 72 and the movement of the needle 58 through the tissue72 maybe performed in any order, or simultaneously, if desired.

In FIG. 5 d, the tissue anchor 62 is illustrated in the process of beingdeployed from the needle 58. As is shown in FIG. 5 d, the suture 64extends through an eyelet 62 a of the tissue anchor 62. Although notillustrated, preferably the tissue anchor 62 is deployed from an end ofthe needle 58 due to the advancement of the push rod 60. Specifically,the push rod 60 may be used to exert a pushing force on the proximalmost tissue anchor 62, which is transferred through the stack of tissueanchors 62 within the needle 58 to deploy the distal most tissue anchor62.

Once deployed, preferably the tissue anchor 62 is positioned on theopposite side of the tissue 72 from the delivery catheter 56 and thesuture 64 extends through the hole in the tissue 72 created by thepassage of the needle 58 through the tissue 72. Thus, when tension isapplied to the suture 64, the tissue anchor contacts the surface of thetissue 72 opposite the catheter 52, which may be the outside surface ofthe heart chamber or vessel, for example. However, in otherarrangements, the tissue anchor may be configured to reside within thetissue 72 and, accordingly, the delivery catheter 58 may not be passedcompletely through the tissue 72 before the anchor is deployed.

As illustrated in FIG. 5 e, once the tissue anchor 62 has been deployed,the needle 58 may be retracted into the delivery catheter 56. Both theneedle 58 and delivery catheter 56 may be retracted within the guidecatheter 54 and away from the tissue 72.

With reference to FIG. 5 f, preferably, the catheter 52 is moved alongthe tissue a desired distance D from the first tissue anchor 62 andanother tissue anchor 62 is deployed, preferably by the same or asimilar method. This process is repeated until a desired number oftissue anchor 62 have been deployed. The distance D may be modified asdesired to suit an individual application. For example, for remodeling alumen, preferably the distance D is adjusted such that preferably atleast three and, more preferably, about 3 to 10 tissue anchors 62 may beimplanted.

FIGS. 6 a and 6 b illustrate multiple tissue anchors 62 interconnectedby a line, such as the suture 64, which may be utilized to reduce thecross-sectional dimension of a tissue wall 90 that defines a cavity orlumen 92. As illustrated, the tissue anchors 62 are positioned atdesired space locations around the circumference of the tissue wall 90and interconnected by the suture 64. With such an arrangement,desirably, very little foreign material is placed across the lumen suchthat blood flow is left relatively or substantially completelyundisturbed.

Preferably, the tissue anchors 62 are generally positioned within asingle plane. However, other suture placement orientations may also beused. Tension may be applied to one or both of the ends 64 a, 64 b ofthe suture 64 to draw the tissue anchors 62 towards one another. As aresult, the cross-sectional dimension of the tissue wall 90 is reduced,as illustrated in FIG. 6 b. The suture ends 64 a, 64 b may then besecured together to secure the tissue wall 90 in a reducedconfiguration. For example, in one arrangement, the ends 64 a and 64 bmay be tied in a knot 94. The knot 94 may be created outside of thecatheter 52 and advanced through the catheter by any suitable method,such as by a conventional knot pusher or other suitable instrument, forexample. Alternatively, the ends 64 a, 64 b may be secured to oneanother by a suitable connector.

FIGS. 7 a and 7 b illustrate a plurality of tissue anchors 62interconnected by a suture 64 and used to fold tissue or, morespecifically in the illustrated arrangement, to collapse a wall oftissue 96 which defines a cavity or lumen 98 and, thus, reduce or closethe lumen 98. In FIG. 7 a and 7 b, instead of being placed sequentiallyaround the circumference of the tissue wall 96, the tissue anchors 62are placed in a non-serial manner. Preferably, the tissue anchors 62 arepositioned generally across the tissue wall 96 from the previouslyplaced tissue anchor 62 and, in some cases, even directly across fromone another such that the suture 64 extends across the lumen or cavity98. Accordingly, when one or both of the ends 64 a, 64 b of the suture64 are pulled, the tissue wall 96 is collapsed onto itself. In a similarmanner to that described above, the suture ends 62 a, 62 b may besecured to one another, such as by a knot 94, for example. Such a methodis well-suited for tubal ligation, such as closing a fallopian tube, forexample.

FIGS. 8 a-8 c illustrate the system 50 being utilized to reduce thevolume of the left ventricle LV of a patient's heart H. In theillustrated arrangement, multiple rows of tissue anchors 62 arepositioned within the wall 100 of the heart H surrounding the leftventricle LV. Preferably, each row of tissue anchors 62 includes its ownsuture 64 and, thus, each suture row may be tightened to a desiredcross-sectional dimension separate from the other rows of tissue anchors62. The tissue anchors 62 may be configured to be passed completelythrough the wall 100 to contact an external surface of the wall 100 ormay be embedded within the tissue wall 100, as desired or necessitatedby the tissue structure being remodeled. Such an arrangement providesessentially an internal basket structure, which preferably is deliveredby a percutaneous transvascular approach, thus providing the benefits ofa conventional compression device while avoiding the disadvantages of aconventional surgical procedure. The rows of implanted sutures 64preferably limit a maximum expanded dimension of the ventricle LV, butdo not limit compression. Adjustment of the suture tension or length,and thus the maximum dimension, may be based on feedback from theejection fraction measurement of the ventricle, for example.

FIGS. 9 and 10 illustrate a preferred embodiment of a tissue anchor 62that may be used in the system 50 described above, or the other systemsdescribed herein. In the illustrated arrangement, the tissue anchor 62is constructed from a generally tubular element. A semi-cylindricalsection of the tubular element is removed from each end, leaving anintermediate portion of the tissue anchor 62 defining an annular loop.The intermediate section of the tissue anchor 62 thus forms an eyelet102 of the tissue anchor 62. Accordingly, the suture 64 may be passedthrough the eyelet 102, with the portions of the tissue anchor 62, oneither side of the eyelet 102 configured to contact the soft tissue andprevent the tissue anchor 62 from being pulled through the passage inthe tissue through which it was passed.

FIGS. 11-14 illustrate another preferred embodiment of a tissue anchor,generally referred to by the reference numeral 104. FIGS. 11 and 12illustrate the tissue anchor 104 in an expanded configuration, whileFIGS. 13 and 14 illustrate the tissue anchor 104 in a collapsedposition. With reference to FIG. 13, the tissue anchor 104 preferably isconstructed from a tubular element that includes a first slot 106 whichextends from a first end of the element toward an intermediate portionof the element and generally bisects the tubular element. Preferably,the slot 106 extends about one-half the length of the tissue anchor 104and, preferably, is aligned with the central axis of the tissue anchor104.

With reference to FIG. 14, preferably a second slot 108 extends from asecond end of the tissue anchor 104 preferably substantially the entirelength of the tissue anchor 104 but terminates prior to the end of thetissue anchor 104 to leave a portion of material 110 at the first end ofthe tissue anchor 104. Preferably, the slot 108 is rotated on thetubular element from the slot 106 and, preferably, is locatedapproximately 90 degrees about the central axis of the tissue anchor 104from the slot 106. Furthermore, preferably the slot 108 passes only oncethrough the wall of the tubular element.

Desirably, the tissue anchor 104 is constructed from a super-elastic, orshape-memory material, such as Nitinol, for example. However, othersuitable materials may be used. Preferably, the tissue anchor 104 isheat set in the expanded position as illustrated in FIGS. 11 and 12,wherein a portion of the tubular element on one side of the slot 106 isbent away from the portion of the other side of the slot 106 until it isgenerally perpendicular to the remainder of the tubular element.Accordingly, in the absence of a biasing force, the tissue anchor 104tends to assume the orientation shown in FIGS. 11 and 12. Preferably,the portion that is bent includes the slot 108 such that the slot 108may function as an eyelet of the tissue anchor 104.

Preferably, the tissue anchor 104 may be constrained, such as by theneedle 58, into the orientation illustrated in FIGS. 13 and 14, or acollapsed orientation, so that the tissue anchors 104 may be deliveredthrough tissue 72. As illustrated in FIG. 15, the tissue anchors 104 maybe deployed in a similar manner to the tissue anchor 62 described above.However, once deployed, preferably the bent portion of the tissue anchor104 including the slot 108 extends partially or completely through thetissue 72. Furthermore, the suture 64 may be passed through the slot 108such that, when tension is applied to the suture 64, the tissue anchor104 applies a force to the surface of the tissue 72 opposite the suture64. With such an arrangement, adjustment of the suture 64 will likely beless affected by friction in comparison to the tissue anchors describedabove because the suture 64 does not pass through tissue.

The above-described system 50 maybe utilized for a number of tissueremodeling applications. For example, with reference to FIGS. 16 a and16 b, the system 50 may be utilized to remodel the aortic valve AV of apatient's heart H. That is, the catheter 52 may be used to place anumber of tissue anchors 62 (or 104) within the aorta A and, preferably,at a location adjacent to the aortic valve AV. In the illustratedmethod, the guide catheter 54 may be omitted from the catheter assembly52 and the delivery catheter 56 may be steerable. As described above,the tissue anchors 62 may be interconnected with a line, such as suture64. Tension applied to the suture 64 draws the tissue anchors 62 towardsone another to reduce the cross-sectional dimension of the aorta A.Accordingly, the leaflets of the aortic valve AV may be remodeled and,preferably, brought towards one another to reduce regurgitation throughthe valve AV. In the illustrated arrangement, the tissue anchors 62 aredisposed on a downstream side of the valve AV. In addition, althoughonly one row of tissue anchors 62 are illustrated, additional rows maybe provided.

With reference to FIGS. 17 a and 17 b, the system 50 also may beutilized to remodel the left ventricle LV to improve the function of themitral valve MV. For example, a plurality of tissue anchors 62 (or 104)may be positioned in a row in a generally circular manner proximate thepapillary muscles PM, which are connected to the leaflets of the mitralvalve MV. The tissue anchors 62 may be interconnected by a line, such asthe suture 64, and tension applied to the suture 64 to draw the tissueanchors 62 towards one another. As a result, the papillary muscles PMmay be drawn toward one another so that the leaflets of the mitral valvemove toward one another, preferably until the leaflets properly coapt toreduce or eliminate regurgitation.

With reference to FIGS. 18-20, the system 50 may be utilized to repair adefect, or hole, within a patient's heart H. With reference to FIG. 18,a septal defect S, such as a patent foramen ovale (PFO), is illustratedin a heart H and, generally, is a hole in the septal wall between theright atrium RA and the left atrium LA. FIG. 19 illustrates the system50 being used to place a plurality of tissue anchors 62 around theseptal defect S. FIGS. 20 a and 20 b illustrate another view of thesystem 50 being utilized to close the septal defect S before and aftertightening of the suture 64, respectively.

FIGS. 21-25 illustrate another system having certain features, aspects,and advantages of the present invention and generally referred to by thereference numeral 150. Similar to the system 50 described above, thesystem 150 is configured to deliver a plurality of tissue anchors tosoft tissue of a patient. The tissue anchors preferably areinterconnected by a line, such as a suture. However, rather thandeploying the tissue anchors one at a time, preferably the system 150 isconfigured to deliver a plurality of tissue anchors simultaneously orsubstantially simultaneously.

The system 150 includes a catheter assembly 152, which preferablyincludes a guide catheter 154 and plurality of delivery tubes 156. Thedelivery tubes 156 are movable within the guide catheter 154 from astowed position (FIG. 21) to a deployed position (FIGS. 22 and 23). Eachof the delivery tubes 156 function in a manner similar to the deliverycatheter 56 described above, or the other delivery catheters describedherein. Thus, the collection of deliver tubes 156 essentially functionas a plurality of delivery catheters, but preferably are sized such thatmultiple tubes 156 may be carried within the guide catheter 154.Preferably, each delivery tube 156 stows a tissue anchor 158. The tissueanchors 158 preferably are interconnected by a line, such as a suture160.

Desirably, the guide catheter 154 is substantially similar to the guidecatheter 54 of FIGS. 1-3. A proximal end of the guide catheter 154defines a handle portion, or hub 162, which permits a user of the system150 to manipulate the guide catheter 154. The guide catheter 154 mayalso be steerable in a manner similar to that described above inconnection with the guide catheter 54 or by any other suitablearrangement. Preferably, the guide catheter 154 is sized such that thelumen is capable of accommodating a desired number of delivery tubes156. In one arrangement, the guide catheter 154 may have a lumendiameter of about 20 to 24 F. However, other suitable dimensions arealso possible, depending on the specific application or number ofdelivery tubes 156 desired. In one arrangement, preferably between about3 and 18 delivery tubes 156 are provided. More preferably, between about8 and 12 delivery tubes 156 are provided for applications involvingremodeling of the aortic valve AV. The guide catheter 154 may beconstructed of any suitable material(s), such as those described above.If desired, the guide catheter 154 could include a braided material, orbe otherwise manipulated, to increase axial or radial stiffness.

Preferably, the delivery tubes 156 are movable within the guide catheter154. The delivery tubes 156 are secured to a proximal handle, or hub164, which permits a user of the system 150 to move the plurality ofdelivery tubes 156 in an axial direction relative to the guide catheter154 substantially simultaneously. Preferably, the delivery tubes 156extend through the guide catheter 154 and are interconnected at the hub164. However, in an alternative arrangement, the delivery tubes 156 maybe coupled to the hub 164 by an intermediate component or components.

Desirably, each of the delivery tubes 156 has a curved distal end 166when deployed from the guide catheter 154. The curved distal end 166extends radially outward from a longitudinal axis of the guide catheter154 preferably such that the distal end surfaces of the deliverycatheters face in a direction generally perpendicular to thelongitudinal axis of the guide catheter 154. Preferably, the curveddistal ends 166 are preshaped such that the distal ends 166 of thedelivery tubes 156 tend to move toward their curved configuration whenno restraining force is present. When stowed within the guide catheter154, the distal ends 166 of the delivery tubes 156 are restrained in agenerally linear configuration and move to the precurved configurationwhen the delivery tubes 156 are deployed from the guide catheter 154.Preferably, the delivery tubes 156 are constructed of a super-elastic orshape-memory material that is manipulated to have the desired curvatureat the distal end 166, as will be appreciated by one of skill in theart.

The distal ends 166 of the delivery tubes 156 are configured to stow atleast one tissue anchor 158. In the illustrated arrangement, each of thedistal ends 166 of the delivery tubes 156 include a slot 168 extendingin an axial direction along the delivery tube 156. The slot 168accommodates the suture 160 in interconnecting the tissue anchors 158while in their stowed position within the delivery tubes 156. However,in other arrangements, the slots 168 may be omitted and the suture 160may enter through the distal end of the lumen of the delivery tubes 156.Further, multiple tissue anchors 158 may be provided, if desired.

FIGS. 24 and 25 illustrate one preferred tissue anchor 158 in stowed anddeployed orientations, respectively. Desirably, the tissue anchor 158includes an eyelet 170 at its proximal end and a pair of barbs 172 atits distal end. Preferably, the barbs 172 converge into a sharp tip 174that permits the tissue anchor 158 to penetrate soft tissue. Once thetissue anchor 158 is advanced into soft tissue, the barbs 172 inhibitwithdrawal of the tissue anchor 158 in response to a pulling forceapplied the tissue anchor 158. Desirably, the tissue anchor 158 is alsoconstructed from a shape-memory material to provide elasticity to thetissue anchors 158. Accordingly, tissue anchors 158 may assume theprecurved shape of the distal ends 166 of the delivery tubes 156.Furthermore, the barbs 172 may be configured to expand outwardly whenthe tissue anchor 158 is deployed from the delivery tube 156 to enhancethe tissue anchor's 158 resistance to removal, as illustrated in FIG.25. The barbs 172 may be held in a restrained position within thedelivery tube 156 prior to deployment, as shown in FIG. 24.

Desirably, a deployment device, such as a pushrod 176, is positionedwithin each delivery tube 156 proximal of the tissue anchor 158.Desirably, a handle, or hub 178 is coupled to each pushrod 176 such thatthe pushrods 176 are advanced within the delivery tubes 156 when apushing force is applied to the hub 178. Accordingly, the hub 178 may bepushed to advance the push rods 176 which, in turn, push the tissueanchors 158 to deploy them from the delivery tubes 156. Because thepushrods 176 are interconnected with the hub 178, the deployment of thetissue anchors 158 occurs substantially simultaneously. However, inalternative arrangements, the tissue anchors 158 may be deployableindependently of one another.

FIGS. 26 a-26 f illustrate the system 150 being utilized to remodel anaortic valve AV to treat aortic insufficiency. Aortic insufficiency orregurgitation is a heart valve disease in which the aortic valve weakensor balloons, preventing the valve leaflets from closing tightly. Thistypically leads to backward flow of blood from the aorta A into the leftventricle LV. Over time, this condition could result in heart failure.Although the system 150 is advantageously well suited for treatment ofaortic insufficiency, it can be used in, or adapted for use in, otherremodeling applications as well.

Similar to the system 50, the catheter 152 preferably is advancedthrough the patient's vasculature to a position downstream from theaortic valve AV, as shown in FIG. 26 a. Once the catheter 152 isproperly positioned, the delivery tubes 156 may be deployed from theguide catheter 154 by advancement of the hub 164. As the delivery tubes156 are advanced from the guide catheter 154, they assume theirpre-curved shape of the distal ends 166 and move toward the wall of theaorta A. Preferably, the delivery tubes 156 are advanced until they passthrough the wall of the aorta A, as illustrated in FIG. 26 b. However,in some arrangements, the tissue anchors 158 may be configured to residewithin the wall of the aorta A and, thus, the delivery tubes 156 may notpass completely through the aorta A. Advantageously, with the system150, the tissue anchors 158 are disposed at a distal-most end of thecatheter 152. That is, preferably no portion of the catheter 152 extendsbeyond the general position of the tissue anchors 158. Accordingly, thetissue anchors 158 may be deployed in close proximity to the valve AV(or other obstructing object) in comparison to devices that deliveranchors proximal of the distal-most end of the device.

Once the delivery tubes 156 are positioned, the tissue anchors 158 maybe deployed from the delivery tubes 156 by advancement of the hub 178,as illustrated in FIG. 26 c. The pushrods 176 and delivery tubes 156 maybe retracted by retraction of the hubs 164 and 178, leaving the tissueanchors 158 disposed within the tissue of the aorta A, as illustrated inFIG. 26 d. As described above, the suture 160 interconnects the tissueanchors 158 and tension may be applied to one or both of the suture ends160 a, 160 b to move the tissue anchors 150 a toward one another andreduce the cross-sectional dimension of the aorta A to achieve thedesired remodeling of the aortic valve AV. Preferably, the suture istightened until the leaflets of the aortic valve AV coapt to inhibit orprevent regurgitation, as illustrated in FIG. 26 e.

FIGS. 27-30 illustrate another preferred system 200, which is configuredto deploy tissue anchors into soft tissue of a patient. The illustratedsystem 200 includes a catheter assembly 202. The catheter assembly 202preferably includes a guide catheter 204, a delivery catheter 206, and atissue anchor deployment member, such as a pushrod 208. The guidecatheter 204, delivery catheter 206 and pushrod 208 are assembledcoaxially and are movable relative to one another, in a manner similarto the systems described above.

A proximal end of the guide catheter 204 defines a handle, or hub 210. Adistal end of the guide catheter 204 preferably is adapted to receive aguide wire 212 (FIG. 30) which may be used to assist in directing thecatheter 202, as is described in greater detail below. Specifically, adistal end of the guide catheter 204 includes an enlarged portion 214that defines a passage 216, which extends in a direction generallyparallel to a longitudinal axis of the guide catheter 204 and to themain lumen of the guide catheter 217. The passage 216 is configured toreceive the guide wire 212 so that the guide catheter 204 may beadvanced or retracted along the guide wire 212. In the illustratedarrangement, the enlarged portion and the passage 216 extends along onlya portion of the distal end of the guide catheter 204, such as about 4to 5 cm in one arrangement to provide for a quick set-up. However, inother arrangements, the passage 216 may extend for other distances, mayextend the entire length of the guide catheter 204 or may be dividedinto a plurality of intermittent passage sections extending along aportion or the entire length of the catheter 204.

The delivery catheter 206 defines a handle, or hub 220 at its proximalend. The hub 220 permits the delivery catheter 206 to be manipulated bya user of the system 200. A distal end of the delivery catheter 206preferably defines a beveled tip 222, which facilitates piercing of softtissue. Desirably, the distal end portion of the delivery catheter 206is configured to have a pre-set curved shape, as illustrated in FIG. 30.For example, the entirety or at least the distal end portion of thedelivery catheter 206 may be constructed from a super-elastic orshape-memory material that is manipulated into a desired curved shape.Accordingly, the guide catheter 204 may function to restrain thedelivery catheter 206 in a generally linear configuration while thedelivery catheter 206 is stowed within the guide catheter 204. However,when the distal end portion of the delivery catheter 206 is deployedfrom the guide catheter 204, the distal end portion of the deliverycatheter 206 tends to move toward its pre-curved shape. With such anarrangement, the longitudinal axis of the guide catheter 204 may begenerally parallel to a surface of the soft tissue 224 and, whendeployed, the distal end portion of the delivery catheter 206 may curveto penetrate the tissue 224 in a direction generally perpendicular tothe longitudinal axis of the guide catheter 204.

The push rod 208 preferably is a solid, cylindrical elongate memberwhich resides within the lumen of the delivery catheter 206. The pushrod208 is movable within the lumen of the delivery catheter 206 and ispositioned proximal of the tissue anchors 226. The pushrod 208 isconfigured to permit a user of the system 200 to deploy the tissueanchors 226 from the catheter 202.

Preferably, a plurality of tissue anchors 226 are loaded within thedelivery catheter 206 to be deployed individually by the pushrod 208.Desirably, the tissue anchors 226 are interconnected by a line, such asa suture 228. Specifically, the suture 228 passes through an eyelet 230of each tissue anchor and, preferably, is secured to the distal mosttissue anchor 226. The free end of the suture 228 extends through thedelivery catheter 206 and exits a proximal end of the catheter assembly202. Tension may be applied to the free end of the suture 228 to drawthe tissue anchors 226 towards one another after they have beenimplanted into tissue 224 to remodel the tissue 224 as desired.Desirably, the distal tip 232 of the tissue anchors 226 include a pairof barbs 234 that inhibit withdrawal of the tissue anchors 226 from thesoft tissue 224.

FIGS. 31-36 illustrate yet another preferred system 250 which isconfigured to deploy a plurality of tissue anchors into soft tissue of apatient. The system 250 includes a catheter assembly 252. The catheterassembly 252 preferably includes a guide catheter 254 and a deliverycatheter 256. In the illustrated arrangement, the guide catheter 254includes a guide passage 258, which is configured to receive a guidewire to permit the guide catheter 254 to be passed over the guide wire,as is described in greater detail below. Preferably, the guide passage258 is similar to the passage 216 of the guide catheter 204, describedabove.

In addition, desirably, the catheter assembly 252 also includes anelastic member, or a linear coil purse string device 260, an extensionrod 262, and an actuator rod 264. Desirably, the linear coil pursestring device 260 may be housed within a distal end portion of the guidecatheter 254 and is carried by the delivery catheter 256, which ismovable within the guide catheter 254. In the illustrated arrangement,the linear coil purse string device 260 is carried outside of the lumenof the delivery catheter 256. The extension rod 262 and actuator rod 264extend through the lumen of the delivery catheter 256 and interact withthe device 260, as is described in greater detail below.

The linear coil purse string device 260 includes a helically wound wire270, having a first end 270 a and a second end 270 b. The first andsecond ends 270 a, 270 b may comprise end caps which encapsulate theends of the coiled wire 270 to inhibit the wire 270 from damagingtissue. The ends 270 a, 270 b may be secured together by a lock nut 271.Specifically, the ends 270 a, 270 b may be received within cavities 271a, 271 b of the lock nut 271, as is described in greater detail below.

Preferably, the coiled wire 270 is constructed from a super-elastic orshape-memory material and is expandable from its relaxed state. However,other stretchable, or elastic, materials or structures may also be used.The wound length of the device 260 is configured according to thespecific anatomical structure into which it is designated forimplantation. In one arrangement, the wire diameter preferably isbetween about 0.002 and 0.015 inches. The inner diameter of the woundcoil (or size of the mandrel on which it may be wound) preferably isbetween about 0.010 and 0.125 inches. However, other suitable dimensionsmay also be used.

Desirably, a plurality of tissue anchor stowage members, or capsules272, are spaced along the coiled wire 270. In one arrangement, thecapsules 272 are positioned about every centimeter along the device 260.The capsules 272 may be secured to the coiled wire 270 by any suitablemechanism or technique, such as swaging, welding or gluing, for example.Preferably, the capsules 272 are generally cylindrical in shape andreside within the interior space defined by the coiled wire 270. Eachtissue anchor stowage capsule 272 preferably houses a tissue anchor 274.The tissue anchor 274 is initially in a stowed orientation within thecapsule 272 and is configured to be deployed therefrom, as illustratedin FIG. 34. The tissue anchor 274 initially resides within a generallycylindrical passage 276 defined by the capsule 272. An exit hole 278communicates with the passage 276 and opens to an outer surface of thecapsule 272. Desirably, the exit hole 278 is configured to permit atleast a portion of the tissue anchor 274 to be deployed from the capsule272.

Preferably, the tissue anchor 274 is substantially similar to the tissueanchors described above, and includes a tissue penetrating tip 280 and,desirably, a pair of barbs 282. The barbs 282 inhibit the tissue anchor274 from withdrawing from tissue once the tissue anchor 274 has beendeployed. The tissue anchor 274 also includes an enlarged head 284opposite the tissue penetrating tip 280. Desirably, the head 284 issized and/or shaped such that the head 284 may not pass through the exithole 278 and, thus, the tissue anchor 274 remains secured to the capsule272 even after deployment.

As described above, the actuator rod 264 extends through the deliverycatheter 256 and through the device 260. A proximal end of the actuatorrod 264 is accessible from external a proximal end of the guide catheter254 and delivery catheter 256 so that the actuator rod 264 may bemanipulated by a user of the system 250. Preferably, the actuator rod264 passes through a space within the coiled wire of the device 260 andthrough the passages 276 of each tissue anchor stowage capsule 272.

The actuator rod 264 includes an enlarged actuation head 266, which isinitially positioned distal of the distal most tissue anchor capsule272. The actuator head 266 of the actuator rod 264 is configured suchthat, when the actuator rod 264 is retracted, the actuator head 266contacts the head 284 of tissue anchor 274 and pushes the tip 280 of thetissue anchor 274 through the exit hole 278. Preferably, the head 284 ofthe tissue anchor 274 moves into the exit hole 278 (and out of thepassage 276) a sufficient distance to permit the enlarged head 266 ofthe actuator rod 264 to pass through the passage 276 and exit thecapsule 272. However, preferably, the tissue anchor 274 is notcompletely separated from the capsule 272. The actuator rod 264 may becontinued to be retracted to deploy the tissue anchor 274 of eachcapsule 272 in a similar manner.

The extension rod 262 is configured to maintain the linear coil pursestring device 260 in an expanded configuration relative to its relaxedconfiguration. That is, the extension rod 262 secures the device 260 inan extended orientation wherein it is longer than its relaxedorientation. The extension rod 262 passes through the delivery catheter256 and through the device 260. A proximal end of the extension rod 262is accessible external of the proximal end of the catheter assembly 252so that the extension rod 262 can be manipulated by a user of the system250.

The extension rod 262 extends through a passage 290 within each of thetissue anchor stowage capsules 272. Preferably, the passage 290 isgenerally parallel to the passage 276. Desirably, the extension rod 262includes a plurality of steps in which the diameter of the extension rod262 increases. Each step 292 contacts a proximal end surface of thecapsule 272 to hold each tissue anchor stowage capsule 272 in a desiredposition relative to each other capsule 272. Thus, preferably, theextension rod 262 includes an equal number of steps 292 as capsules 272.Desirably, the spacing of the steps 292 determines the length ofextension of the device 260. Preferably, the diameter of the extensionrod 262 decreases in a direction from the proximal end toward the distalend such that the extension rod 262 may be retracted withoutinterference between the steps 292 and the tissue anchor stowagecapsules 272. Thus, once the extension rod 262 is retracted, the linearcoil purse string device 260 is permitted to move from its extendedorientation toward its relaxed orientation and remodel the tissue inwhich the device 260 is implanted.

The above described systems 200 and 250, as well as the system 50 ofFIGS. 1-3, are particularly well suited for remodeling the leftventricle of a patient's heart. In one method of remodeling the leftventricle, access to the left ventricle is through a transeptal path.That is, access to the left ventricle is gained by creating an accesspassageway through the septal wall SW between the right ventricle RV andthe left ventricle LV and passing the catheter from the right ventricleRV, through the septal wall SW, to the left ventricle LV. FIGS. 37 and38 illustrate one preferred access pathway P for gaining access to theleft ventricle LV of a patient's heart H. Such an approachadvantageously reduces or minimizes the potential complications ofcrossing the aortic valve in the case of a retrograde approach, orcrossing the atrial septal and the mitral valve in the case of anantegrade approach.

FIGS. 39 a through 39 h illustrate the system 50 of FIGS. 1-3 beingutilized to remodel the left ventricle LV of a patient's heart H andreaching the left ventricle LV along an access path P as shown in FIGS.37 and 38. As illustrated in FIG. 39 a, the catheter 52 is introducedthrough vasculature to the right ventricle. Once in place within theright ventricle RV, the distal end of the catheter 52 is abutted againstthe septal wall SW, preferably near a junction of the septal wall SW andthe outer wall, or anterior wall portion, of the heart H (FIG. 39 b). Atranseptal device 300 is utilized to create an access pathway throughthe septal wall (FIG. 39 c) and the catheter 52 is advanced through thepassageway (FIG. 39 d). Preferably, the transeptal device 300 is aconventional device known in the art for creating a transeptalpassageway, such as a Mullins sheath, for example. However, othersuitable devices or methods may also be used.

The catheter 52 is then advanced toward a desired tissue location withinthe left ventricle LV, such as a junction between the septal wall SW andthe external wall of the heart H opposite the access pathway, asillustrated in FIG. 39 e. Tissue anchors 302, which may be of anysuitable construction, such as one of the various constructionsdescribed above, are introduced at desired spaced locations preferablyin a semi-circular pattern within the external wall of the heart H (FIG.39 f). Desirably, when used in this method, one end of the suture 64 issecured to the first tissue anchor 302. Once the tissue anchors 302 havebeen positioned, preferably the free end of the suture 64 is passedthrough the access passageway within the septal wall SW and pulled tightto draw the tissue anchors 302 towards one another to remodel the leftventricle LV, as illustrated in FIG. 39 g.

A retaining structure, such as a knot 304, can then be created in thesuture 64 within the right ventricle RV to abut the septal wall SW tosecure the tissue anchors 302 in the desired spacing to maintain theremodeling of the left ventricle LV. As described above, the knot 304may be created outside of the patient and advanced through the catheter53 by a suitable device, such as a knot pusher. Preferably, in somearrangements, a pledget (not shown) or similar member is positionedbetween the septal wall SW and the knot 304 to increase the surface areaacting on the septal wall SW and inhibit the knot from being pulledthrough the septal wall SW. In addition, other alternative devices ormethods for maintaining tension on the suture 64 may also be used. Theillustrated method has the advantage of using the septal wall SW as aback stop for tying off the suture 64, which is a relatively simplemethod of maintaining tension on the suture 64.

FIGS. 40 a-40 j illustrate another preferred method for remodeling theleft ventricle LV of a patient's heart H. In this illustrated method,preferably, the system 200 of FIGS. 27-30 is utilized. Initially, afirst catheter 320 and a guide wire 322 are routed through vasculatureto the right ventricle RV and through the septal wall SW to the leftventricle LV. A second catheter 324 is similarly advanced to the leftventricle LV, preferably to an opposite side of the left ventricle LVfrom the first catheter 320 and through a separate access passageway, asillustrated in FIG. 40 a.

A retrieval device 326 is advanced through the second catheter 324 andis used to grasp the guide wire 322, as shown in FIG. 40 b. Theretrieval device 326 may be of any suitable construction to permit theretrieval of the guide wire 322, such as one of the devices disclosed inU.S. Pat. No. 5,522,819 or U.S. Pat. No. 5,868,754, for example, theentireties of which are incorporated by reference herein and made a partof this specification. The guide wire 322 can then be pulled through thesecond catheter 324 such that both ends of the guide wire 322 arelocated external of the patient. The catheters 320 and 324 may then beremoved from the patient, leaving the guide wire 322 in place, asillustrated in FIG. 40 c.

The user of the system 200 may apply a force to the free ends of theguide wire 322 to force the portion of the guide wire 322 within theleft ventricle LV against the interior surface of the wall of the heartH, as shown in FIG. 40 d. Accordingly, the guide wire 322 may be used toreduce the amount of motion due to the heart beat during deployment ofthe tissue anchors 226. Subsequent to the positioning of the guide wire322, the catheter 202 may be advanced over the guide wire 322 until adistal end portion of the catheter 202 is within the left ventricle LV,as shown in FIG. 40 e. Tissue anchors 226 may then be deployed withinthe external wall of the left ventricle LV as described above withreference to FIGS. 27-30 and shown in FIG. 40 f.

Once all the anchors had been placed, tension may be applied to thesuture 228 interconnecting the tissue anchors 226 to draw the tissueanchors 226 towards one another and remodel the left ventricle.Preferably, a knot 328 may be created in the free ends of the suture 228external of the patient and advanced through the catheter 202 to securethe free ends together and maintain tension on the suture 228, asillustrated in FIG. 40 g. Preferably, the knot 328 is positioned withinthe right ventricle RV such that the portion of the suture 228 and knot328 rest against the septal wall SW within the right ventricle RV tomaintain the left ventricle LV in its remodeled orientation, asillustrated in FIG. 40 h. This method may be used to reduce to thevolume of the left ventricle LV to treat congestive heart failure or toreposition the papillary muscles to improve mitral valve function, amongother therapeutic uses.

FIGS. 41 a and 41 b illustrate a similar method using the system 250 ofFIGS. 31-36. In this method, once the linear coil purse string device260 has been implanted within the left ventricle LV, the ends 270 a and270 b are secured together within the right ventricle RV, such as by thelock nut 271 (as described above with reference to FIG. 33) or anothersuitable method. As described above, the tissue anchors 274 may bepositioned within the heart H while the device 260 is in a stretchedstate. Desirably, the stretched state of the device 260 is no more thanabout 6 to 8 percent of the elastic limit of the material. Once theextension rod 262 is removed, the device 260 preferably retracts towardsits relaxed state, thereby remodeling the left ventricle LV. Theresistance to stretching of the device 260 assists in inhibitingexcessive enlargement of the ventricle LV. This method may be used toreduce to the volume of the left ventricle LV to treat congestive heartfailure or to reposition the papillary muscles to improve mitral valvefunction, among other therapeutic uses.

With reference to FIGS. 42 a and 42 b, as will be appreciated by one ofskill in the art, multiple rows R of tissue anchors may be implantedwithin the left ventricle LV. For example, with reference to 42 a, themultiple rows R may converge at a common point and be inclined relativeto one another. Alternatively, the multiple rows R may be positionedsubstantially parallel to one another, depending on the desired shape ofthe remodeled ventricle. Other suitable relative orientations of therows R of tissue anchors may also be used, including arrangementswherein two or more rows R intersect with one another.

FIGS. 43-46 illustrate yet another system 350 for remodeling soft tissueof a patient. Preferably, the system 350 includes a catheter assembly352. The catheter assembly 352 preferably includes a guide catheter 354and a delivery catheter 356. A tunneling device 358 is received withinthe delivery catheter 356.

Desirably, the delivery catheter 356 has a pre-curved distal end portion360 that may be constrained in a generally linear configuration whenpositioned within the guide catheter 354. However, when deployed fromthe guide catheter 354, the distal end portion 360 of the deliverycatheter 356 preferably tends to move toward its pre-curvedconfiguration. As described above, the pre-curved shape of the deliverycatheter 356 may be configured by heat setting or otherwise manipulatinga super-elastic or shape-memory material. Furthermore, the distal end ofthe guide catheter 354 may be deflectable, such as in a manner similarto the guide catheters described previously.

The tunneling device 358, preferably is an elongate rod with a tissuepenetrating tip 362. The tip 362, in one arrangement, may include one ormore helical flutes such that when the tunneling device 358 is rotated,the tip 362 tends to facilitate passage through tissue. The tunnelingdevice 358 preferably is constructed from a super-elastic orshape-memory material to provide a desired degree of flexibility.However, other suitable materials may also be used, such as stainlesssteel, for example.

The delivery catheter 356 and tunneling device 358 may be advanced androtated relative to one another and the guide catheter 354 to permit thetunneling device 358 to move through tissue in a desired tunneling path.Preferably, the tunneling device 358 is configured to carry an end of asuture or other line, through the passage created by the tunnelingdevice 358, as is described in greater detail below. However, in otherarrangements, the tunneling device 358 may be configured to carry othersuitable cinching devices, such as an elastic member similar to thecoiled member 270, with or without the tissue anchor capsules 272.

FIG. 47 illustrates one desired path Q for the tunneling device 358 tofacilitate placement of a suture to remodel the left ventricle LV of apatient's heart H. In addition, FIGS. 48 a through 48 h illustrate apreferred method of utilizing the system 350 to pass a cinching member,such as suture 364, through the heart wall and around the left ventricleLV. With reference to FIG. 48 a, preferably by methods similar to thosedescribed immediately above, access is gained to the right ventricle RVthrough the patient's vasculature. A catheter 362 preferably is utilizedto gain access to the right ventricle RV and provide a path to permitthe catheter assembly 352 to be advanced through the catheter 362 to theright ventricle RV. Once inside the right ventricle RV, the catheterassembly 352 is positioned at a junction J of the septal wall SW and theexternal wall of the heart H. The tunneling device 358 may be advancedfrom the guide catheter 354 by a pushing force and, preferably,simultaneous rotation so that the tip 362 bores into the tissue.

With reference to FIG. 48 b, the guide catheter 354 and the deliverycatheter 356 may be advanced along the tunneling device 358 after thetunneling device 358 has created a path through the heart wall. Thedelivery catheter 356 may be advanced from the guide catheter 354 suchthat the distal end portion 360 of the delivery catheter 356 assumes adesired pre-curved configuration. Accordingly, the delivery catheter 356may be used as a steering device to urge the tunneling device 358 in adesired direction. The extent that the delivery catheter 356 is exposedfrom the guide catheter 354, along with the rotational position of thedelivery catheter 356 relative to the guide catheter 354, may beselected and modified throughout the procedure to achieve a desiredtunneling path of the tunneling device 358. In this manner, asillustrated successively in FIGS. 48 c through 48 g, the tunnelingdevice 358 may be steered in a path through the external wall of theheart H circumscribing the left ventricle LV until the tunneling device358 reenters the right ventricle RV, preferably at a junction betweenthe septal wall SW and external wall of the heart H opposite its entrypoint. A retrieval tube, or retrieval catheter 364, may be introduced tothe right ventricle RV by a suitable method to receive the tip of thetunneling device 358 so that the device 358 may be advanced through thecatheter 362 until it may be retrieved from the proximal end of theretrieval catheter 364.

Accordingly, such a method permits the tunneling device 358 to not onlycreate a tunnel, or passage, through the heart wall, but to also pass acinching device, such as the suture 364, through the passage. The suture364, or other cinching device, may then be pulled, or cinched, toremodel the left ventricle LV. Preferably, as illustrated in FIG. 48 h,the suture 364 is tied off into a knot to maintain the remodeledorientation in a manner similar to that described above. Pledgets may beused if desired to spread the load acting on the heart wall from theknot to a larger area. The system 350 and described method may be usedto remodel the left ventricle LV, such as reducing the volume to treatcongestive heart failure or repositioning the papillary muscles toimprove mitral valve function. In addition, the system 350 and methodmay be used to remodel other body cavities as well.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. For example, the present systems may be utilized for tissueattachment, tissue compression, tissue cinching, tissue tying, tissueremodeling, tissue apposition and holding tissue in a desired position.Furthermore, while the present tissue remodeling systems and methodshave been described in the context of particularly preferredembodiments, the skilled artisan will appreciate, in view of the presentdisclosure, that certain advantages, features and aspects of the systemmay be realized in a variety of other applications, many of which havebeen noted above. Additionally, it is contemplated that various aspectsand features of the invention described can be practiced separately,combined together, or substituted for one another, and that a variety ofcombination and sub-combinations of the features and aspects can be madeand still fall within the scope of the invention. Thus, it is intendedthat the scope of the present invention herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims.

1. A method, comprising: positioning a distal end of a catheterproximate a body structure; providing a piercing member containing aplurality of tissue anchors, each tissue anchor comprising a tubularelement having a longitudinal passage defining an inner surfaceextending along an entire longitudinal length of the tissue anchor, eachtissue anchor forming an eyelet; providing a purse string that passesentirely through the longitudinal passage and entirely along the innersurface of each of the tissue anchors when the tissue anchors are withinthe piercing member; securing the tissue anchors to tissue of the bodystructure comprising advancing the piercing member into a wall of thebody structure by passing the piercing member through an inner surfaceof the wall of the body structure, deploying at least one of the tissueanchors from said piercing member such that at least a portion of thetissue anchor on each side of the eyelet contacts the outer surface ofthe wall of the body structure and the eyelet is generally perpendicularto the remainder of the tubular element when deployed and the pursestring passes through the eyelet and is capable of applying a force toeach of the tissue anchors once deployed; and applying force to thepurse string to draw at least some of said tissue anchors towards eachother.
 2. The method of claim 1, further comprising securing said pursestring to maintain said tissue anchors in said drawn together position.3. The method of claim 2, wherein said securing said purse stringcomprises joining the free ends of said purse string to one another. 4.The method of claim 2, wherein said securing comprises securing one freeend of said purse string to one of said tissue anchors and securing theother free end to the body structure.
 5. The method of claim 1, whereinat least one of the tissue anchors has a collapsed position and anexpanded position, the eyelet is generally perpendicular to theremainder of the tubular element in the expanded position when deployed.6. The method of claim 5, wherein the at least one of the tissue anchorshas a first slot aligned with a central axis of the tubular element, thefirst slot forming the longitudinal passage, and an intermediate sectionhas a second slot generally perpendicular about the central axis fromthe first slot, the second slot forming the eyelet.
 7. The method ofclaim 6, wherein the second slot functions as the eyelet.
 8. The methodof claim 1, wherein securing the tissue anchors comprises: securing thetissue anchors at or proximate the papillary muscles to improve mitralvalve function.
 9. The method of claim 1, wherein said providing thepurse string comprises: providing the purse string extending through thecatheter such that both ends of the purse string are external of aproximal end of the catheter.
 10. The method of claim 1, wherein thepurse string passes through the eyelets when deployed.